WO2024026529A1 - Préparation pour le traitement d'une stéatose hépatique non alcoolique (nafld) - Google Patents

Préparation pour le traitement d'une stéatose hépatique non alcoolique (nafld) Download PDF

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WO2024026529A1
WO2024026529A1 PCT/AU2023/050713 AU2023050713W WO2024026529A1 WO 2024026529 A1 WO2024026529 A1 WO 2024026529A1 AU 2023050713 W AU2023050713 W AU 2023050713W WO 2024026529 A1 WO2024026529 A1 WO 2024026529A1
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prebiotic
fibre material
sugarcane
phytonutrient
nafld
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PCT/AU2023/050713
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English (en)
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Marisa PILLA
Tanvi Shinde
Kent Taylor
Gordon Edwards
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Health Food Symmetry Pty Ltd
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Priority claimed from AU2022902151A external-priority patent/AU2022902151A0/en
Application filed by Health Food Symmetry Pty Ltd filed Critical Health Food Symmetry Pty Ltd
Publication of WO2024026529A1 publication Critical patent/WO2024026529A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • A23L33/22—Comminuted fibrous parts of plants, e.g. bagasse or pulp
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
    • A23V2200/3202—Prebiotics, ingredients fermented in the gastrointestinal tract by beneficial microflora
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
    • A23V2200/3204—Probiotics, living bacteria to be ingested for action in the digestive tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K2035/11—Medicinal preparations comprising living procariotic cells
    • A61K2035/115—Probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Definitions

  • the invention relates to the field of food supplement manufacture and therapeutic manufacture.
  • the invention relates to a combination of virgin sugarcane prebiotic and probiotic strains, the synbiotic combination of the combination in the diet of an individual, and the improved outcomes of the synbiotic approach in the prophylaxis and/or treatment and management of non-alcoholic fatty liver disease (NAFLD) risk factors.
  • NAFLD non-alcoholic fatty liver disease
  • Non-alcoholic fatty liver disease is characterised by excessive fat accumulation, i.e., steatosis, without significant alcohol consumption. Liver steatosis is defined as fat accumulation in >5% of hepatocytes [1].
  • NAFLD can be sub-divided into two types - simple steatosis or non-alcoholic fatty liver (NAFL) without inflammation and non-alcoholic steatohepatitis (NASH).
  • NAFL non-alcoholic fatty liver
  • NASH non-alcoholic steatohepatitis
  • NAFL can progress from simple liver steatosis (fatty liver) to NASH. The latter (due to inflammation in the liver and liver damage) has a potential progressive course leading to liver fibrosis, cirrhosis and hepatocellular carcinoma [2].
  • NAFLD is the most common cause of chronic liver diseases in Western countries, affecting up to 40% of general population and sometimes reaching 90% [3].
  • the clinical burden of NAFLD is not only confined to liver-specific morbidity and mortality, but there is growing evidence that NAFLD is a multi-system disease affecting extra-hepatic organs and regulatory pathways.
  • NAFLD increases risk of type-2 diabetes mellitus (T2DM), cardiovascular disease and chronic kidney diseases [4].
  • NAFLD neurodegenerative disease
  • T2DM insulin resistance
  • hypertension hyperlipidaemia
  • NAFLD and metabolic syndrome both increase the risk of cardiovascular disease and T2DM and are therefore likely to have similar risk profiles [3].
  • the leading cause of death in NAFLD patients is not liver failure, but cardiovascular disease [5].
  • the prevalence of NAFLD is 80-90% in obese adults, 30-50% in patients with diabetes and up to 90% in patients with hyperlipidaemia.
  • the prevalence of NAFLD among children is 3-10%, rising up to 40-70% among obese children [6] .
  • NAFLD pathogenesis is complex and not fully understood. It is, however, understood that NAFLD is caused by complex interplay of multiple factors including poor diet, insulin resistance, and other metabolic disturbances. Additional risk factors include host factors (genetics and epigenetics) and lifestyle -related factors like sleep shortage, irregular food intake, sedentary habits, and excessive weight gain [7].
  • the gut microbiome includes several trillion bacteria with a combined bacterial genome of 100 times as many genes as the human genome. Key roles assigned to gut microbiota include maintenance of mucosal integrity and defence, development of innate immunity, and energy harvest from dietary sources. Alterations in the gut microbiome have been linked to a range of illnesses, including obesity and NAFLD.
  • NAFLD is commonly associated with compositional and functional alterations of gut microbiota known as dysbiosis.
  • Gut microbiota analysis in NAFLD compared with healthy subjects noted reduced commensal bacteria abundance in the gram-positive Firmicute phylum and increased opportunistic pathobionts such as those from the gramnegative Proteobacterial phylum [3] [5].
  • the gut dysbiosis in NASH promotes a proinflammatory environment, which results in increased gut permeability. Increased gut permeability can cause the translocation of endotoxin lipopolysaccharides (LPS), bacteria, and antigens into the portal circulation and thence into the liver, resulting in hepatic inflammation [10].
  • LPS endotoxin lipopolysaccharides
  • Inflammation which is the key pathological characteristic of NASH, is a major mediator promoting the development of NASH and progression to cirrhosis and hepatocellular carcinoma. Many factors could be involved in the NASH inflammatory process, including genetics, epigenetic, environmental agents, nutritional, and adverse shifts in the gut microbiota [10].
  • Synbiotics being a combination of probiotic and prebiotic ingredients that interact positively, can potentiate prophylactic and therapeutic effects that may function synergistically to confer health benefits. This is critical when selecting probiotic and prebiotic ingredients for synbiotic combination for efficient functioning and significant efficacy.
  • a unique prebiotic phytonutrient fibre extract from sugarcane, manufactured to preserve the cell wall components provides a representative cellular fibre component from plant dietary sources. While sugarcane fibre has historically been labelled as an insoluble fibre, improved fibre analysis techniques and studies into the fermentability of sugarcane fibrous matter reveals uniform fermentability of the insoluble fibre characteristics and fibrous sub-structures by bacteria, specifically those that reside and can function in the colon. Providing this complex and more nature-equivalent nutrient source to the microorganisms of the colon, including functional delivery of sugarcane’s characterised antioxidant bioactives (phenolics, flavonoids, and polycosanols), delivers a positive pressure on maintaining or increasing microbial diversity, rather than the reduction of diversity with limited complexity prebiotic s.
  • sugarcane’s characterised antioxidant bioactives
  • probiotics have been affirmed to exert beneficial effects on the host.
  • An additional factor that may influence the beneficial effects of probiotics is their ability to generate fermentation products that influence the composition and function of the gut microbiome. This, in turn, can potentially improve the health of the host.
  • Bacteriocins and organic acids are two possible antimicrobial products that can be produced by probiotics to influence and stabilise the gut microbiome.
  • SCFAs short-chain fatty acids
  • the probiotic effect could, therefore, be potentiated by co- supplementation with prebiotic dietary fibres that can be metabolised and fermented by the administered probiotic, as well as by beneficial microflora in the gut.
  • the resulting production of metabolites can direct the shift of immune markers from pro-inflammatory to antiinflammatory phenotype.
  • a synbiotic approach potentially offers greater success of colonisation and survivability of beneficial bacteria owing to the advantageous effects that can be achieved compared to using either probiotics or prebiotics alone [14][15], [0019]
  • beneficial byproducts of microbial fermentation such as short chain fatty acids
  • the delivery of plant antioxidants and supplying a known beneficial probiotic
  • the synergistic effects can be optimised beyond the sum of its parts.
  • Kfibre® is a complex prebiotic dietary fibre sourced from virgin sugarcane with the sugar removed and has been reported to influence gut health in several studies involving inflammatory bowel disease (IBD) mouse models, human GERD/acid reflux trials and animal/human in vitro faecal studies.
  • IBD inflammatory bowel disease
  • Kfibre in a synergistic combination with probiotic is also confirmed to amplify the anti-inflammatory and immunomodulatory effects in both models of IBD.
  • Kfibre-based synbiotic administration was confirmed to prevent and/or enhance the gut barrier integrity, reduce pro -inflammatory markers in the serum (CRP and cytokines), increase SCFA production along the colon and modulate microbiota diversity.
  • CRP and cytokines pro -inflammatory markers in the serum
  • SCFA production SCFA production along the colon and modulate microbiota diversity.
  • Kfibre weight loss study Kfibre supplementation has been reported to cause significant weight loss (10.06 kg in females and 9.97 kg in males) compared to those who were not administered Kfibre (5.70 and 6.41 kg, respectively).
  • the sugarcane fibre has been previously demonstrated to impart positive effects on human gut microbiota in vitro, particularly influencing the abundance of members of family Bifidobacteriaceae [16]. Compared with the other dietary fibre supplements tested (wheat dextrin and psyllium husk), the sugarcane fibre was reported to show highest availability of polyphenols and antioxidant potential.
  • GSD gastroesophageal reflux diseases
  • Another object of an another especially preferred form of the present invention is to provide a synergistic combination of a prebiotic fibre extract from sugarcane and probiotics that ameliorates the effects/inflammatory states of NAFLD, as a long-term prophylactic treatment by inclusion into the regular diet.
  • a “synbiotic” is a combination of prebiotic plant fibre from sugarcane and a probiotic bacterial strain or postbiotic byproduct for use in all subsequent formats, formulations and purposes.
  • the synbiotic in most cases, includes but is not limited to, a combination of dry prebiotic and dry probiotic spores, lyophilised or live stabilised bacteria.
  • the synbiotic can also be the combination in an aqueous solution for use in food manufacturing procedures.
  • a “postbiotic” should be construed in accordance with the definition ascribed to it by the International Scientific Association for Probiotics and Probiotics (ISAPP), which in 2019 convened a panel of experts specialising in nutrition, microbial physiology, gastroenterology, paediatrics, food science and microbiology to provide a consistent and credible definition for the term.
  • the panel defined a “postbiotic” as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host”.
  • Effective postbiotics must contain inactivated microbial cells or cell components, with or without metabolites, that contribute to observed health benefits.
  • the panel also discussed existing evidence of health-promoting effects of postbiotics, potential mechanisms of action, levels of evidence required to meet the stated definition, safety and implications for stakeholders.
  • the panel determined that a definition of postbiotics is useful so that scientists, clinical triallists, industry, regulators and consumers have common ground for future activity in this area, see, https://www.nature.com/articles/s41575-021- 00440-6.
  • a “carrier” is a palatable substrate for the sugarcane fibre, which may or may not contain protein or other nutrients.
  • the carrier can be in a solid or liquid form, including but not limited to: fruit extracts, broths, purees, dairy products, baked goods.
  • An “inert filler’ is any product used to increase the bulk of fibre according to the invention to allow for ease of handling by the user.
  • the filler may contain flavours or nutrients, and other dietary fibres to improve mouth feel, but does not necessarily contribute to the total benefit provided by the invention.
  • a “pellet” includes any compact form of the invention, including but not limited to: a dried pill or tablet in the manner of a vitamin or a “soft lolly” style lozenge that may be used as a treat or as an addition to other foods.
  • the phrase “consisting of’ excludes any element, step, or ingredient not specified in the claim.
  • the phrase “consists of’ (or variations thereof) appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole.
  • the phrase “consisting essentially of’ limits the scope of a claim to the specified elements or method steps, plus those that do not materially affect the basis and novel characteristic(s) of the claimed subject matter.
  • a “heaped teaspoon” of Kfibre® is 1.5 g. Therefore, when taken twice a day, the daily amount of Kfibre® is 3 g.
  • the probiotic (L. plantarum 299v (DSM 9843)) is generally taken once daily for the first five days, and then twice daily thereafter.
  • Metagenics Ultra Flora GI Soothe is a commercial preparation comprising 20 billion CFU per capsule, resulting in a daily dosage (post day 5) of 40 billion CFU.
  • the ratio of prebiotic to probiotic is therefore 1.5 to 3 g prebiotic to 20-40 billion CFU probiotic for live probiotic bacterial cells.
  • the present invention relates generally to the combination of a prebiotic sugarcane fibre and probiotic strains, and the synbiotic use of the combination in the diet of an individual for the prophylaxis and/or treatment of NAFLD.
  • composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain for prophylaxis and/or treatment of the effects of NAFLD.
  • the prebiotic phytonutrient fibre material prepared from virgin sugarcane is Kfibre®.
  • the prebiotic phytonutrient fibre material prepared from virgin sugarcane, which is washed and chopped, and the sugary juice removed. The leftover plant is dried and ground into a fibre powder. Around 95% of the sugar is removed.
  • the prebiotic phytonutrient fibre material prepared from virgin sugarcane, freshly harvested and manufactured to retain phytonutrients and intact cell wall vegetable fibre.
  • the resultant product is 100% sugarcane fibre (95% sucrose removed) which has a composition of ⁇ 87% fibre.
  • the other 13% comprises natural sugars, waxes, minerals, vitamins, plants sterols and antioxidants.
  • the prebiotic phytonutrient fibre material is prepared via a process including the steps of: subjecting sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the fibre, and to enhance the water retention properties of the residual fibre product.
  • the wet diffusion step is a diffusion extraction, performed under relatively low-shear conditions.
  • the wet diffusion step is performed within the temperature range of about 25 °C to about 70 °C.
  • composition can further comprise a pharmaceutically acceptable carrier, solvent, base and/or excipient.
  • Sugarcane fibre prepared using the steps described above also has several advantageous properties compared to purified/isolated plant fibres such as bran, psyllium husk and inulin.
  • the fibre prepared from sugarcane is a true lignose, hemicellulose and cellulose combination, like the total dietary fibres found in most vegetables.
  • Pectin is a significant component (about 10%) of cell walls, and being a soluble, metabolisable fibre, could also play a role in the activity of the sugarcane fibre as a prebiotic.
  • Other components of the sugarcane fibre include xylan (which is soluble) and arabinoxylan polymers.
  • the sugarcane fibre can be classed as almost entirely insoluble fibre, using standard chemical methods of classification, however, it has many of the properties of soluble fibres such as high water-binding capacity (up to 8-10 times by weight) and a prebiotic effect by acting as a substrate for microbial fermentation in the colon to generate beneficial metabolites including SCFAs.
  • the at least one probiotic bacterial strain can be commercially sourced from bacterial strains that are known and correlated to the reduction of chronic gut inflammation or to the support of the normal function of the gastrointestinal tract.
  • at least one probiotic bacterial strain is spore-forming, thereby providing robustness to survive and retaining viability in the colon of a host.
  • the at least one probiotic bacterial strain can be heat stable to ensure viability during manufacture.
  • the at least one bacterial strain can be acid stable, allowing the at least one bacterial strain to remain viable in the host colon after administration.
  • the at least one probiotic bacterial strain is spore-forming, heat stable and acid stable.
  • the at least one probiotic bacterial strain is selected from the group consisting of: Bacillus coagulans, Lactobacilli (L. plantarum, L. paracasei, L. acidophilus, L. casei, L.rhamnosus, L. crispatus, L. gasseri, L. reuteri, L. bulgaricus), Bifidobacterium (B. longum, B. catenulatum , B. breve, B. animalis, B. bifidum), Streptococcus (S. sanguis, S. oralis, S. mitis, S. thermophilus, S. salivarius), Bacillus (B. subtilis, B.
  • Lactococcus (L. lactis), Enterococcus (E. faecium), Pediococcus (P. acidilactici), Propionibacterium (P. jensenii, P. freudenreichii), Pep to streptococcus (P. productus), Saccharomyces (S. boulardii) and Akkermansia muciniphila.
  • a food product comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain for prophylaxis and/or treatment of the effects of NAFLD.
  • a food product comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain.
  • composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, for prophylaxis and/or treatment of the effects of NAFLD.
  • composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, for ameliorating the effects of NAFLD.
  • compositions for ameliorating the effects of NAFLD comprising prebiotic fibre material prepared from sugarcane, and at least one probiotic bacterial strain.
  • a food product for ameliorating the effects of NAFLD comprising prebiotic fibre material prepared from sugarcane.
  • a food product for ameliorating the effects of NAFLD comprising prebiotic fibre material prepared from sugarcane, and at least one probiotic bacterial strain.
  • the food product can be utilised in the diet for a defined period of time for ameliorating the effects of NAFLD.
  • the food product can be utilised in the diet over a prolonged period of time, including indefinitely, to ameliorate the effects of NAFLD and/or as a prophylactic for NAFLD.
  • a prebiotic phytonutrient fibre material prepared from sugarcane in the manufacture of a therapeutic for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain in the manufacture of a therapeutic for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • a prebiotic phytonutrient fibre material prepared from sugarcane in the manufacture of a food product for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain in the manufacture of a food product for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • a composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one postbiotic.
  • a postbiotic is a non-viable bacterial product or metabolic by-product from probiotic microorganisms that has biologic activity in the host.
  • a postbiotic is a fragment or metabolite of a probiotic.
  • the composition can further comprise a pharmaceutically acceptable carrier, solvent, base and/or excipient.
  • the at least one postbiotic can be commercially-sourced.
  • the at least one postbiotic is sufficiently robust to survive in the colon.
  • the at least one postbiotic can be heat stable to ensure viability during manufacture.
  • the at least one postbiotic can be acid stable, allowing the at least one postbiotic to remain viable in the colon after administration.
  • the at least one postbiotic is heat stable and acid stable.
  • the at least one postbiotic can be selected from the group consisting of short-chain fatty acids, antimicrobial peptides, nutrients (including amino acids and vitamins such as vitamin K and B-vitamins), carbohydrate-active enzymes.
  • a food product comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one postbiotic.
  • compositions for ameliorating the effects of NAFLD comprising prebiotic fibre material prepared from sugarcane, and at least one postbiotic.
  • a food product for ameliorating the effects of NAFLD comprising prebiotic fibre material prepared from sugarcane, and at least one postbiotic.
  • the food product can be utilised in the diet for a defined period of time for ameliorating the effects of NAFLD.
  • the food product can be utilised in the diet over a prolonged period of time, including indefinitely, to ameliorate the effects of NAFLD and/or as a prophylactic for NAFLD.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one postbiotic in the manufacture of a therapeutic for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one postbiotic in the manufacture of a food product for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • a method of treating or ameliorating the effects of NAFLD in a subject comprising administering to the subject a composition provided by the second or thirteenth aspects, or a food product provided by the third or fourteenth aspects.
  • Figure 1 is a graph showing the effects of the synbiotic on serum GGT of NAFLD subjects 1-7 as described below.
  • Figure 2 is a graph showing the effect of the synbiotic on body weight of NAFLD subjects 1-7 as described below.
  • the present invention takes advantage of the properties of a prebiotic fibre produced from sugarcane in such a way that maximises retention and minimises destruction of the bioactive molecules.
  • the present inventors have surprisingly found that such a prebiotic fibre is effective in the prophylaxis and/or treatment of inflammatory states associated with NAFLD.
  • the method of preparation of the prebiotic fibre material from sugarcane is broadly similar to that described in International Patent Publication WO 2011/035381, to KFSU Pty Ltd; this document is incorporated herein by reference in its entirety.
  • the preparatory method according to the present invention can be generally described in the following steps: a sugarcane size reduction step; a relatively gentle aqueous extraction step that separates the fibre from other sugarcane fractions, including the sugar fraction, without causing degradation of the fibre functionality; and a relatively gentle drying step that minimises degradation of the fibre functionality.
  • the aqueous extraction step be an aqueous diffusion extraction performed at about neutral pH. It is also preferred that the drying step be a rapid vortex drying operation that can be achieved via a low temperature vortex dryer, the dryer being able to reduce the wet weight of the sugarcane material from 40-80% wet weight to less than 10% wet weight in 10-30 seconds while not heating the material to a level that would significantly damage the bioactives in the plant material.
  • the invention provides for the use of a synbiotic, namely, a prebiotic fibre from sugarcane combined with selected probiotics or postbiotics, in the formulation of foods, diets or therapeutics that reduces the risk of development of NAFLD conditions, or which ameliorates the symptoms of those conditions.
  • the synbiotic combination has a number of advantages over other fibre sources and food, including that: it is relatively hypoallergenic; it contains both insoluble and bound soluble fibre in beneficial proportions for dietary intake; it can be prepared in a ‘chemical-free’ manner and contains no harmful trace elements, unlike fibre from other sources such as chemically modified starch; it can be prepared in such a way as to retain the micronutrients and active molecules found in the “molasses” component of sugarcane, without the need to extract and purify those components for their biological function; and it can be prepared in such a manner to optimize the bioactivity of the prebiotic and also maximise viability of the probiotic or its by-products (postbiotics).
  • dietary fibre intake can be more easily controlled with a sterically hindered restricted rate of microbial metabolism.
  • a synbiotic according to the invention is pressed into a pellet or added to a flavouring medium and pressed into a pellet. Due to the inherent stability of the prebiotic and selected probiotics, the synbiotic pellets are prepared at a formulation level such that the dose may be varied according to a patient’s requirements to reduce the symptoms of NAFLD without incurring negative effects.
  • a synbiotic is mixed with a flavoured drink (for example a non-acidic fruit juice or milk) and pasteurised (1-5 g per 100-250 mL).
  • a drink prepared in this manner is a convenient, ready-to-consume product for the amelioration of NAFLD.
  • pasteurisation sterilises the preparation.
  • a supplement is prepared as an easy-to-measure powder with or without flavours, stabilisers and inert filler, formulated specifically to be combined with water.
  • a synbiotic can be mixed with a dry flavour component and an inert filler to form easy-to-use granules.
  • the dose e.g., 1-5 g
  • the resultant supplement is best suited to allow reduced meal size, as the granules can be mixed with water (thereby allowing less food to be consumed each meal).
  • a synbiotic is prepared in a solid flavoured meal such as a biscuit, a bar, or a bread (baked) product (0.5-5.0 g per serve of ready mixed food).
  • a solid flavoured meal such as a biscuit, a bar, or a bread (baked) product (0.5-5.0 g per serve of ready mixed food).
  • Multiple biscuits, bars or bread products can be consumed by an individual to provide a specific dosing regimen and optimise compliance of the treatment. This has three principal advantages over other delivery systems in that it feels more like a treat for the consumer, it eliminates the need for liquid, and reduces the total volume of the stomach contents.
  • the increased saliva production may have a complementary effect with the synbiotic benefits.
  • Subject 1 [AM] - 50-year-old female with medically diagnosed fatty liver and reflux, overweight and with prescribed medication of Coversyl (perindopril) 5 mg daily. In addition, the subject wished to lose weight and was seeking help with bloating.
  • the subject was prescribed one heaped teaspoon of Kfibre twice a day, 229v probiotic once daily for five days, then twice a day along with her medication of Coversyl 5 mg daily.
  • the subject was recommended to drink 2 L filtered water daily and follow a wellness diet plan, exercise three times a week and have outside time in nature at least once a week. After six weeks, the GGT levels in the subject dropped from 73 to 50 U/L and she experienced significant weight loss of 78 into 68 kg.
  • Subject 2 [AM] - 49-year-old male with medically diagnosed fatty liver where ultrasound showed infiltration of liver by fat deposits and overweight.
  • the subject was prescribed one heaped teaspoon Kfibre twice a day, 229v probiotic one daily for five days then twice a day, one tablespoon collagen powder and one tablespoon whey powder once a day, male multivitamin once a day, plus a general lifestyle and dietary advice similar to that of Subject 1.
  • the subject also followed the Metagenics keto diet eating plan. After six weeks, the blood GGT level of the subject dropped from 92 to 43 U/L and the subject experienced weight loss of 120 into 109 kg.
  • Subject 3 [VK] - 53-year-old female with medically diagnosed fatty liver, reflux, overweight, perimenopause and with prescribed medication of Avapro (irbesartan) 150 mg once daily.
  • the subject was prescribed one heaped teaspoon Kfibre twice a day, 229v probiotic once daily for five days then twice a day, plus female multivitamins and mineral, magtabs (magnesium 200 mg with zinc 10 mg) daily, in addition to following a general lifestyle and dietary advice similar to that of Subject 1. After six weeks, the subject’s blood GGT levels dropped from 87 to 53 U/L and the subject experienced weight loss of 69 into 60 kg.
  • Subject 5 [MF] - 55-year-old female with medically diagnosed fatty liver, reflux, cyst on kidney, overweight and experience tiredness. The subject also reported bloating with too much milk/dairy and was allergic to penicillin.
  • Avapro HCT irbesartan and hydrochlorothiazide
  • the subject was prescribed one heaped teaspoon Kfibre twice a day, 229v probiotic once daily for five days then twice a day.
  • the subject was cautioned to avoid dairy.
  • the subject was additionally prescribed prime essential (multimineral and vitamin with Vitamin E), CoQlO 150 mg each once daily, mega magnesium tablet once daily plus followed general lifestyle and dietary advice similar to that of Subject 1.
  • GAD generalised anxiety disorder
  • Subject 7 [FS] - 65-year-old male with medically diagnosed fatty liver, reflux, panic attacks, osteoarthritis and experience tiredness, panic attacks and has bad taste in mouth.
  • the gut microbiota has a significant impact on intrahepatic fat accumulation; however, the mechanisms are yet to be fully determined.
  • the interaction between the liver and gut, that is, the gut-liver axis, could explain the beneficial role of gut microbiota composition for NAFLD.
  • Applicant’s evidence suggests that targeting the axis using prebiotics, probiotics or synbiotics may be an appropriate approach for treating NAFLD and for management of its risk factors.
  • EASL Liver
  • EASD Diabetes
  • EASO Obesity
  • EASO E.A. for the S. of EASL-EASD-EASO Clinical Practice Guidelines for the Management of Non-Alcoholic Fatty Liver Disease. OFA 2016, 9, 65-90, doi: 10.1159/000443344.
  • a composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain for prophylaxis and/or treatment of the effects of NAFLD.
  • composition according to statement 1 wherein each probiotic bacterial strain is present as spores and/or live cells.
  • composition according to statement 1 wherein the composition is in a form selected from the group consisting of a pellet, food product, and drink.
  • composition according to statement 1 wherein the prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • composition according to statement 1 further comprising a pharmaceutically acceptable carrier, solvent, base or excipient.
  • composition according to statement 1 wherein said prebiotic phytonutrient fibre material comprises almost the entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • composition according to statement 1 wherein the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a food product comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain for prophylaxis and/or treatment of the effects of NAFLD.
  • prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a food product comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain.
  • a food product according to statement 14 wherein the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • a food product according to statement 14, wherein the prebio tic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, for prophylaxis and/or treatment of the effects of NAFLD.
  • prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, for ameliorating the effects of NAFLD.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a composition for ameliorating the effects of NAFLD the composition comprising prebiotic fibre material prepared from sugarcane, and at least one probiotic bacterial strain.
  • each probiotic bacterial strain is present as spores and/or live cells. 34.
  • the composition is in a form selected from the group consisting of a pellet, food product, and drink.
  • composition according to statement 32 wherein the prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • composition according to statement 32 further comprising a pharmaceutically acceptable carrier, solvent, base or excipient.
  • composition according to statement 32 wherein said prebiotic phytonutrient fibre material comprises almost the entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • composition according to statement 32 wherein the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a food product for ameliorating the effects of NAFLD comprising prebiotic fibre material prepared from sugarcane, and at least one probiotic bacterial strain.
  • a food product according to statement 45 wherein the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a prebiotic phytonutrient fibre material prepared from sugarcane in the manufacture of a therapeutic for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain in the manufacture of a therapeutic for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a prebiotic phytonutrient fibre material prepared from sugarcane in the manufacture of a food product for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one probiotic bacterial strain in the manufacture of a food product for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebio tic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a composition comprising a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one postbiotic.
  • a composition according to statement 75 wherein each probiotic bacterial strain is present as spores and/or live cells.
  • a composition according to statement 75, wherein the composition is in a form selected from the group consisting of a pellet, food product, and drink.
  • the prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • a composition according to statement 75 further comprising a pharmaceutically acceptable carrier, solvent, base or excipient.
  • composition according to statement 75 wherein said prebiotic phytonutrient fibre material comprises almost the entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a food product comprising a prebiotic phytonutrient fibre material extracted from sugarcane, and at least one postbiotic.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • a food product according to statement 82 wherein said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • composition for ameliorating the effects of NAFLD comprising prebiotic fibre material extracted from sugarcane, and at least one postbiotic.
  • composition according to statement 88 wherein the prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • composition according to statement 88 further comprising a pharmaceutically acceptable carrier, solvent, base or excipient.
  • composition according to statement 88 wherein said prebiotic phytonutrient fibre material comprises almost the entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • composition according to statement 88 wherein the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a food product for ameliorating the effects of NAFLD comprising prebiotic fibre material prepared from sugarcane, and at least one postbiotic.
  • a food product according to statement 95 wherein the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • a food product according to statement 95 wherein said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • a food product according to statement 95 wherein the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one postbiotic in the manufacture of a therapeutic for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a prebiotic phytonutrient fibre material prepared from sugarcane, and at least one postbiotic in the manufacture of a food product for ameliorating the symptoms and/or inflammatory states of NAFLD, or for providing a prophylactic effect.
  • the prebiotic phytonutrient fibre material is administrable in a form selected from the group consisting of a composition, pellet, food product, and drink.
  • each said probiotic bacterial strain is present as spores and/or live cells.
  • said prebiotic phytonutrient fibre material is sucrose-reduced sugarcane fibre.
  • said prebiotic phytonutrient fibre material comprises almost an entire insoluble fibre content of sugarcane, comprising a lignose, hemicellulose and cellulose combination, including pectin, xylan and arabinoxylan polymers.
  • the prebiotic phytonutrient fibre material is prepared using a process comprising the steps of: subjecting the sugarcane to at least one wet diffusion step to separate sugars from a residual fibre material whilst maintaining nutrient content; and, subjecting the residual fibre material to a rapid, low-heat drying process to retain biologically active molecules in the residual fibre material and to enhance water retention properties of said residual fibre material, to thereby produce the prebiotic phytonutrient fibre material.
  • a method of treating or ameliorating the effects of NAFLD in a subject comprising administering to the subject a composition defined according to any one of statements 1-7, 32-38, 75-81 or 88-94, or a food product as defined according to any one of statements 14-19, 45-50, 82-87 or 95-100.
  • a composition, use, method or food product according to any one of the preceding statements wherein the ratio of prebiotic to probiotic in the synbiotic is between about 1.5 to 3.0 g prebiotic to between about 20 to 40 billion CFU probiotic.

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Abstract

L'invention concerne une composition comprenant une matière de fibres de phytonutriments prébiotiques préparée à partir de canne à sucre, et au moins une souche bactérienne probiotique pour le traitement prophylactique et/ou thérapeutique des effets d'une stéatose hépatique non alcoolique (NAFLD). Un autre mode de réalisation de l'invention comprend un produit alimentaire comprenant une matière de fibres de phytonutriments prébiotiques préparée à partir de canne à sucre, et au moins une souche bactérienne probiotique. Un autre mode de réalisation de l'invention comprend l'utilisation d'une composition comprenant une matière de fibres de phytonutriments prébiotiques préparée à partir de canne à sucre pour le traitement prophylactique et/ou thérapeutique des effets de la NAFLD.
PCT/AU2023/050713 2022-08-01 2023-07-31 Préparation pour le traitement d'une stéatose hépatique non alcoolique (nafld) WO2024026529A1 (fr)

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AU2022902151A AU2022902151A0 (en) 2022-08-01 Preparation for the treatment of non-alcoholic fatty liver disease (NAFLD)
AU2022902151 2022-08-01

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Citations (5)

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Publication number Priority date Publication date Assignee Title
JP2001302533A (ja) * 2000-04-21 2001-10-31 Shin Mitsui Sugar Co Ltd 肝機能増強剤
WO2015071811A1 (fr) * 2013-11-18 2015-05-21 Kfsu Ltd Complément alimentaire pour le traitement du reflux acide et du reflux gastro-oesophagien pathologique (gord/gerd)
JP2015202057A (ja) * 2014-04-11 2015-11-16 喜信 大城 食物繊維入りヨーグルトの製造方法
WO2015188235A1 (fr) * 2014-06-13 2015-12-17 Gratuk Technologies Pty Ltd Complément alimentaire
WO2019237152A1 (fr) * 2018-06-15 2019-12-19 University Of Tasmania Préparation pour le traitement d'une maladie intestinale inflammatoire à l'aide d'un extrait fibreux végétal entier provenant de canne à sucre

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001302533A (ja) * 2000-04-21 2001-10-31 Shin Mitsui Sugar Co Ltd 肝機能増強剤
WO2015071811A1 (fr) * 2013-11-18 2015-05-21 Kfsu Ltd Complément alimentaire pour le traitement du reflux acide et du reflux gastro-oesophagien pathologique (gord/gerd)
JP2015202057A (ja) * 2014-04-11 2015-11-16 喜信 大城 食物繊維入りヨーグルトの製造方法
WO2015188235A1 (fr) * 2014-06-13 2015-12-17 Gratuk Technologies Pty Ltd Complément alimentaire
WO2019237152A1 (fr) * 2018-06-15 2019-12-19 University Of Tasmania Préparation pour le traitement d'une maladie intestinale inflammatoire à l'aide d'un extrait fibreux végétal entier provenant de canne à sucre

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CASTILLO VALENTINA, FIGUEROA FERNANDA, GONZÁLEZ-PIZARRO KAROLL, JOPIA PAZ, IBACACHE-QUIROGA CLAUDIA: "Probiotics and Prebiotics as a Strategy for Non-Alcoholic Fatty Liver Disease, a Narrative Review", FOODS, M D P I AG, CH, vol. 10, no. 8, CH , pages 1719, XP093140088, ISSN: 2304-8158, DOI: 10.3390/foods10081719 *
TANVI SHINDE, PERERA AGAMPODI PROMODA, VEMURI RAVICHANDRA, GONDALIA SHAKUNTLA V., KARPE AVINASH V., BEALE DAVID J., SHASTRI SONIA,: "Synbiotic Supplementation Containing Whole Plant Sugar Cane Fibre and Probiotic Spores Potentiates Protective Synergistic Effects in Mouse Model of IBD", NUTRIENTS, vol. 11, no. 4, 1 April 2019 (2019-04-01), pages 1 - 25, XP055670594, DOI: 10.3390/nu11040818 *
WANG, YU, ZHANG, FLOYD, LIAN, CEFALU, BOUDREAU: "Comparing the effects of nano-sized sugarcane fiber with cellulose and psyllium on hepatic cellular signaling in mice", INTERNATIONAL JOURNAL OF NANOMEDICINE, DOVE MEDICAL PRESS, NEW ZEALAND, vol. 7, New Zealand , pages 2999 - 3012, XP093140050, ISSN: 1178-2013, DOI: 10.2147/IJN.S30887 *

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